Summary

Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason
for children to visit a physician. In many countries it is the most common reason to
prescribe antibiotics leading to increased drug-resistance of the causative agents, or to
undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5
billion dollar annually in the United States. Prevention is suspected to be an important
solution to this problem.

Although OM management has no universal standard yet, it may imply watchful waiting,
antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future)
vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within
2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly
detected OME resolves within 3 months. However, in a significant part of the OM population
persistent or recurrent episodes of OM are responsible for a significant morbidity for both
children and parents, despite variable treatment options.

Through the set up of a new prospective cohort in a clinical setting, relevant patient
characteristics, the role of bacterial and viral pathogens, the role of recurrent infection
in relation to biofilm formation, and the host response at protein level will be studied in
detail. This project is expected to increase the understanding of the underlying mechanisms
of OM disease, which will support future treatment and prevention strategies. Better
understanding in OM pathogenesis is warranted in order to develop these novel preventive
strategies.

Children 0-5 years of age suffering from chronic suppurative otitis media and waiting for tympanostomy tube insertion. Note: Only 3 patients with CSOM were recruited and therefore not suitable for publication.

Primary Outcomes

Measure

Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease

time frame:
01-06-2009 to 01-06-2010

Secondary Outcomes

Measure

Otitis media demography

time frame:
15-04-2008 to 01-01-2010

Bacterial and viral pathogen detection

time frame:
15-04-2008 to 01-01-2010

Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens

time frame:
15-04-08 to 01-01-2010

Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis

time frame:
01-06-2009 to 01-06-2010

Eligibility Criteria

Male or female participants up to 5 years old.

Inclusion Criteria:
- children up to 5 years of age
- suffering from rAOM, COME or CSOM
- waiting for tympanostomy tube insertion
- informed consent
Exclusion Criteria:
- No informed consent
- The child has a malignancy, or organ transplantation, or immune deficiency in the
medical history
- The child had recent elective ear surgery (i.e. mastoidectomy, implants <2 weeks ago)
- The child suffers from systemic infectious diseases (i.e. hepatitis, chickenpox)

Additional Information

Official title

Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media